FDAnews Drug Daily Bulletin

EMA Side-Effects Reporting System to Go Offline for Upgrade

Oct. 9, 2017

The EudraVigilance online adverse-reporting system run by the European Medicines Agency will be down partially or fully from Nov. 8 to Nov. 21 to accommodate an upgrade, the EMA said.

The downtime won’t interrupt reporting of drug side effects to national health agencies by doctors and patients, with alternate reporting methods filling in. The online data base also will remain available to the public.

Under the new system, drug companies no longer will need to submit adverse-event reports to individual national regulatory agencies, instead submitting reports to EudraVigilance only. And member states no longer will need to submit data to the World Health Organization, with EudraVigilance providing that information directly to WHO’s Uppsala Monitoring Centre.

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